Notifiable Low Risk Dealings (NLRDs) are activities with GMOs undertaken in containment (i.e. not released into the environment) that have been assessed as posing low risk to the health and safety of people and the environment provided certain risk management conditions are met.
The types of dealings with GMOs classified as NLRDs are specified in Schedule 3 of the Gene Technology Regulations 2001 (the Regulations). An excerpt of Schedule 3 is available on the NLRD Documents and Forms page to assist with NLRD classification. An NLRD may only be undertaken after it has been assessed as being an NLRD by an Institutional Biosafety Committee (IBC).
Approval process to conduct an NLRD
1. A person/accredited organisation submits an NLRD proposal to an IBC
It is strongly recommended that the OGTR’s Guidance Document is used when preparing an NLRD proposal (see the NLRD Documents and Forms page).
2. IBC assesses NLRD
3. IBC prepares a Record of Assessment
- the dealing must be assessed by an IBC as being an NLRD
- the dealing must be mentioned in parts 1 or 2, and not in part 3, of Schedule 3 of the Regulations
- IBC assess the suitability of people and facilities proposed for the dealings.
IBCs must prepare a Record of Assessment (RoA) for each proposed NLRD they assess, and give a copy of this RoA to the person/accredited organisation who submitted the proposal.
It is recommended that the OGTR’s Model Form is used, or referred to, when preparing a RoA (see the NLRD Documents and Forms page).4. Commencement
The NLRD can commence once the RoA is received.5. NLRDs must be conducted:
6. Notify the Regulator of the NLRD
- only as described in the IBC RoA
- by people with appropriate training and/or experience
- within a facility certified to either Physical Containment level 1 (PC1), PC2 or PC3 (as appropriate), or another facility specifically approved in writing by the Regulator for a particular NLRD, and in accordance with any conditions imposed on the facility, and.
- transported, stored and disposed of according to the Regulator’s Guidelines for the Transport, Storage and Disposal of GMOs, or alternative conditions specifically approved in writing by the Regulator for a particular NLRD.
The person/accredited organisation who submitted the proposal to the IBC, must notify the Regulator of any NLRDs assessed during the financial year. Due to the 2019 amendments to the Regulations, NLRDs can be notified at any time from the date of assessment until the 30th September of the following financial year. In the event that the organisation is accredited under the Gene Technology Act 2000, reporting of NLRDs must occur prior to an accredited organisation’s annual report to the Regulator. The NLRD reporting form must be used and instructions for completing the form are available on the NLRD Documents and Forms page.
7. List of NLRDs updated on the OGTR website
NLRDs notified to the Regulator are assigned a reference number (NLRD number) by the OGTR. NLRDs reported to the Regulator are published on the OGTR website as part of the Record of GMO Dealings. The list of NLRDs is updated quarterly
All abovementioned forms and other relevant information relating to NLRDs can be found on the NLRD Documents and Forms page. For further information see the Frequently asked Questions - Accreditation, Institutional Biosafety Committees (IBCs) & Notifiable Low Risk Dealings (NLRDs) page on the website.